Director, Quality Inspection Management

Celldex Therapeutics, Inc.; Hampton, Northern (VA, KY); Hybrid; USD 177,000 - 229,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking a Director to architect and lead its inspection management program, ensuring readiness for FDA/International inspections, partner audits, and commercial launch activities.

The role collaborates across Quality, Manufacturing, Regulatory Affairs, Clinical Development, and Commercial functions to sustain a robust inspection readiness framework, supporting Celldex's move toward commercial operations while maintaining global regulatory compliance.

Qualifications

• 10+ years in QA, GMP compliance, regulatory inspection management, or quality systems.
• Experience leading FDA and international regulatory inspections.
• Direct experience with CMOs and global supply networks.
• Experience managing Health Authority responses and CAPA follow ups.
• Biologics, monoclonal antibodies, sterile products, or advanced therapeutics preferred.
• Clinical-stage and commercial-stage environment experience preferred.

Responsibilities

• Create an Inspection Management Program for Celldex and CDMOs.
• Create a living inspection readiness program for Celldex and CDMOs.
• Work with the Quality CDMO Management team on Health Authority inspection topics.
• Establish a Health Authority Inspection Management Process for Celldex and CDMOs.
• Oversee responses to Health Authority inspections.
• Ensure CAPA follow-ups are completed on time (100%).
• Develop metrics to track performance.

Skills

Quality Assurance

GMP Compliance

Regulatory Inspection Mgmt

Cross-Functional Leadership

Leadership

Risk Based Decision Making

Stakeholder Management

Education

Bachelor's degree in Life Sciences/Pharmacy/Engineering/Chemistry/Microbiology

Job description

Overview

This role will serve as the primary architect and leader of Celldex's inspection management program, ensuring continued state of readiness for regulatory authority inspections, partner audits, and commercial launch activities.

The Director will collaborate across Quality, Manufacturing, Supply Chain, Technical Operations, Regulatory Affairs, Clinical Development, and Commercial functions to establish and maintain a sustainable inspection readiness framework. The successful candidate will play a key role in supporting Celldex's transition from a clinical-stage organization to a commercial biotechnology company while ensuring compliance with FDA, EMA, MHRA, Health Canada, ICH, and other global regulatory requirements. This individual will provide leadership for GMP compliance initiatives, inspection preparation, audit response management, quality risk mitigation, and continuous improvement activities throughout the product lifecycle.

Responsibilities

• Creation of an Inspection Management Program for Celldex and our Contract Development and Manufacturing Organizations (CDMO).
• Creation of a living inspection readiness program to ensure Celldex, and its CDMOs remain inspection ready.
• Work with the Quality CDMO Management team to ensure "Hot Topics" at our CDMOs are prepared for prior to Health Authority Inspections.
• Establishment of a Health Authority Inspection Management Process for Celldex, and for our CDMOs.
• Responsible for the response process for all Health Authority Inspection.
• Responsible for ensuring CAPAs created by Health Authority Inspections are followed up on and are complete on time 100% of the time.
• Development of metrics to track performance

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.
• Minimum 10+ years of experience in Quality Assurance, GMP Compliance, Regulatory Inspection Management, or Quality Systems within biotechnology, pharmaceuticals, or biologics manufacturing.
• Demonstrated experience leading FDA and international regulatory inspections.
• Direct experience working with CMOs and global supply networks.
• Experience managing Health Authority responses and CAPA follow ups
• Experience supporting biologics, monoclonal antibodies, sterile products, or advanced therapeutics preferred.
• Experience within both clinical-stage and commercial-stage environments strongly preferred.
• Experience with commercial launch readiness and post-approval quality operations highly desirable.
• Patient Focused
• Strategic Leadership
• Cross-Functional Stake Holder Management
• Balanced Judgement
• Risk Based Decision Making
• Results Driven

Compensation Statement

The expected base salary for this position is: $176659.00 to $229427.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.